1. Field of Invention
The embodiments herein generally relates to a topical formulation useful for the treatment of pain, inflammation and symptoms related to gout, rheumatic disorders, and, more particularly to a micro-emulsion based synergistic herbal formulation and a process of preparation of the same in pharmaceutical acceptable dosage forms. Further more specifically, the embodiments is concerned with the therapeutic properties of the formulation to be applied topically for the treatment of rheumatic disorders and related infections including arthritis, gout, fibromyalgia, ankylosing spondylitis, osteomyelitis, bone TB. Even more specifically, the present embodiment is concerned with the topical treatment using the said formulations having rapid and efficient penetration, increased rate of absorption, increased bioavailability, low irritation, better efficacy and synergistic bacteriostatic activity of therapeutic agents.
2. Description of the Related Art
Rheumatic disorders, including arthritis, gout, fibromyalgia, ankylosing spondylitis are characterized by inflammation and pain in bones, joints, muscles, and related connective tissues. Arthritis is a common progressive disease of various etiologies. Rheumatoid arthritis is a chronic syndrome characterized by non-specific usually symmetric inflammation of the peripheral joints, potentially resulting in progressive destruction of articular and per-articular structures leading to deformity. There is a wide spectrum of disease severity but many patients run a course of intermittent relapses and remissions with an overall pattern of slowly progressive joint destruction. Persistent inflammation produces symptoms and damages tissue causing loss of cartilage, erosion of bone matter and subluxation of joint. This results in a high degree of morbidity resulting in disturbed daily life of the patient. Bone and joint inflammation is a scourge of both animals and humans. Those who suffer from inflammation experience pain and discomfort and may, in advanced cases, lose the effective use of inflamed joints.
A bacterial injection of a joint can also cause a severe and potentially destructive form of arthritis, often referred to as septic arthritis. Bacterial joint infections can be caused by a number of different organisms and can occur in both natural and artificial joints (eg, after a knee replacement).
Natural ingredients, e.g., herbs, have been used to treat bone and joint inflammation, (Long et al; Rheumatology 2001; 40: 779-793, Teekachunhatean et al; BMC Complemetary and Alternative Medicine 2004; 4:19) especially in eastern countries; and, increasingly, in western countries. Some of the commonly used herbs are extracts of Withania somnifera, Boswellia serrata, Zingiber officinale, Curcuma longa in tablet form (Soeken et al; Rheumatology 2003; 42: 652-659). Compositions composed of natural ingredients used for the treatment of pain and inflammation are disclosed, in U.S. Pat. Nos. 5,494,668; 5,683,698; 5,916,565; 5,888,514; 5,854,291; 5,908,628; 5,788,971, 5,910,307, 7,531,194 and PCT/SG2007/000284. Prior arts disclose various formulations in oral/topical form using herbal ingredients but still fail to solve the problem of spreading this kind of diseases which are reported to be growing at rate of 13.67%. Arthritis limits the activity of over 7 million people in US alone, and is second only to heart disease as a cause of work disability. Recent estimates, place the direct medical cost of arthritis at $15.2 billion per year, with total costs of medical care and lost wages exceeding $64 billion.
This is because there was technical barrier to develop herbal formulations in new drug delivery system as disclosed in the current embodiment that can provide an additional benefits in terms of technological advancements.
Prevalent treatment of Rheumatoid diseases includes first line drugs for control of pain and inflammation classified as non-steroidal, anti-inflammatory drugs (NSAIDS). Secondary treatment include corticosteroids, slow acting anti-rheumatic drugs (SAARDS) or disease modifying (DM) drugs include penicillin amine like drugs such as cyclophosphamide, methotrexate, gold salts, azothioprine, levamisole. All these drugs have severe side effects and most of them are cytotoxic.
Some of the micro-emulsion based formulations have been disclosed in U.S. Pat. Nos. 6,638,537, 6,638,522, 4,647,586 using phenyl butazone, sulindac, penicillamine, salsalate, piroxicam, azathioprine, indomethacin, meclofenamate sodium, gold sodium thiomalate, ketoprofen, diclofenac, auranofin, aurothioglucose, tolmetin sodium, colchicine, allopurinol, cyclosporin and other NSAIDs. These formulations are for oral administration only and thus cause huge side effects, and have complications related to multi drug administration, thus fail to provide safe and effective therapy for better patient compliance. Frequently, anti-inflammatory medicaments cause abnormalities in the bowel tract e.g. bleeding.
The drugs used till date have limited advantages and their effects mainly of short term duration and there are many disadvantages in the use of these drugs over extended periods of time. Further the drugs used at present are costly and have low-benefit risk ratio. The ideal formulation to modify the progress of the disease have not been found heretofore.